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Serious Non-Compliance. Continuing Non-Compliance. Unanticipated Problems Involving Risk to Subjects or Others.

A reportable event is any event that the IRB may determine is an unanticipated problem involving risks to subjects or others or serious or continuing noncompliance with the federal regulations or Institutional Review Board requirements.

Depending upon the nature and seriousness of the non-compliant activity, the IRB may take the following actions: Require a response from the investigator with a plan for corrective actions. Require the investigator to complete additional human participants protection training. Initiate audits of the active protocols.

If IRB regulations are not followed, consequences could include: suspension of the research project or of all of a primary investigator's research projects; inability to use or publish research results; notification of noncompliance to sponsors, regulatory agencies, and funding agencies; inability to receive federal ...

Unanticipated Problem Involving Risk to Human Subjects or Others: Any accident, experience, new information or outcome that meets all of the following criteria: Unexpected in terms of nature, severity, or frequency; Related, or possibly related, to a subject's participation in the research;

You may report your concern(s) by any of the following method(s): Call the Human Subjects Office mainline (319) 335-6564 and indicate you would like to report a complaint or concern. Your call will routed to Compliance staff. E-mail irb@uiowa.edu.

Human Research Protection Program (HRPP)

How to submit incident reports. , unless an institution lacks the ability to do so. If an institution or IRB is unable to submit incident reports using the online form, a written explanation of why the institution or IRB is unable to use the online form to submit the report must be emailed to OHRP-DCO@hhs.gov.